Quality Engineer I
Carlisle Interconnect Technologies

Carlsbad, California

Posted in Manufacturing and Production


This job has expired.

Job Info


SUMMARY

The Quality Engineer is responsible for the overall quality of the facility and also responsible for maintaining and improving the Quality System, data analysis, quality practices and continuous improvement activities.

ESSENTIAL JOB FUNCTIONS

* Directs quality assurance activities for all current and future medical products.
* Establishes and updates Quality Systems based on changes to pertinent regulations, audit observations and changes to existing products and processes.
* Manage and performs activities associated with CAPA, Complaints, Non-Conforming Materials, Risk Management, Sterilization Validation, Packaging, Biocompatibility Statistical Analysis, Inspection and Calibration.
* Proposes regulatory strategy for new and modified products
* Conducts device/regulatory research to support submissions and amendments, including 510ks and corresponding international submissions, including Technical files.
* Assembles reports, amendments, supplement, and letters to file etc. to support regulatory submissions.
* Develops and establishes SOP's according to regulatory requirements
* Oversees qualify and manage overall Supplier base
* Leads others in the quality department through implementation and maintenance of the company quality system, reporting on the performance of the quality system for review and as a basis for improvement of the quality system.

*Other duties as required in support of the department and the company*

SUPERVISOR RESPONSIBILITIES

None

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Work is performed in a normal office environment with minimal physical risks involved. The noise level in the work environment is low to moderate.

Carlisle Interconnect Technologies is a clean facility, housing different kinds of machinery, equipment, processes and chemicals which produce potential hazards in the work environment such as: ergonomic, chemical, machine point of operation, and powered industrial vehicle traffic. These hazards are controlled through means of engineering controls, such as machine guarding, and administrative controls, such as safety policies and programs. In certain areas of the facility, employees are required to wear Personal Protective equipment such as Hearing Protection, Safety Glasses, Safety Toe Shoes, and hand protection.

PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS

* ASTM F-2412-2005, ANSI Z41-1999, or ANSI Z41-1991 rated safety toed shoes
* Clear ANSI Z87.1 safety rated glasses

ENVIRONMENTAL POLICY

Carlisle Interconnect Technologies is dedicated to identifying and reducing the environmental impact of its operations, activities, and products. It is our commitment to comply with all applicable laws and other regulatory requirements concerning the environment. We are committed to preventing pollution and continually improving our environmental performance in all our global operations. This will be achieved through a comprehensive Environmental Management System that provides the framework for setting and reviewing environmental objectives and targets of Carlisle Interconnect Technologies.

TRAVEL

10%

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential job function satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Appropriate education and/or experience may be substituted on equivalent basis

* Bachelors and/or advanced degree in a science or technical area or equivalent
* 4-7 years related experience and/or training; or equivalent combination of education and experience.
* Medical Device experience is a plus.

CERTIFICATES, LICENSES, REGISTRATIONS

* Six Sigma Black Belt certification a plus.

LANGUAGE SKILLS

* Ability to read, write, speak and understand English.

* Proficient written and verbal communication skills.
* Ability to read and understand verbal and written instructions, read blueprints, drawings and schematics.

JOB SKILLS

* Strong fundamental understanding of ISO 13485 requirements
* A CQE is preferred but not required.
* Skilled at analyzing data and summarizing.
* Microsoft Office

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel, and talk or hear. The employee frequently is required to reach with hands and arms. The employee is required to stand and walk. The employee must occasionally lift walk. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled


This job has expired.

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